- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00069108
A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
3. marts 2016 opdateret af: Hoffmann-La Roche
An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Bolus and Continuous Infusion Fluorouracil/ Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX4") as Treatment for Patients With Metastatic Colorectal Cancer Who Have Received Prior Treatment With CPT-11 in Combination With 5-FU/LV as First Line Therapy
This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer.
Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles.
The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
627
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Bruxelles, Belgien, 1070
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Bruxelles, Belgien, 1000
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Gent, Belgien, 9000
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Kortrijk, Belgien, 8500
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Mont-godinne, Belgien, 5530
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
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Ontario
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London, Ontario, Canada, N6A 4L6
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Oshawa, Ontario, Canada, L1G 2B9
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Ottawa, Ontario, Canada, K1H 1C4
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Saint Catherines, Ontario, Canada, L2R 2Z7
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Thunder Bay, Ontario, Canada, P7A 7T1
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Toronto, Ontario, Canada, M5G 2M9
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Weston, Ontario, Canada, M9N 1N8
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Quebec
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Laval, Quebec, Canada, H7M 3L9
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Levis, Quebec, Canada, G6V 3Z1
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Montreal, Quebec, Canada, H1T 2M4
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Montreal, Quebec, Canada, H2W 1S6
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Montreal, Quebec, Canada, H4J 1C5
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Quebec City, Quebec, Canada, G1R 2J6
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
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Denbigh, Det Forenede Kongerige, LL18 5UJ
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Manchester, Det Forenede Kongerige, M20 4BX
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Merseyside, Det Forenede Kongerige, CH63 45Y
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Preston, Det Forenede Kongerige, PR2 9HT
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Tampere, Finland, 36280
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Turku, Finland, 20520
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California
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Bakersfield, California, Forenede Stater, 93309
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80903
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20007-2197
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Indiana
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Terre Haute, Indiana, Forenede Stater, 47802
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Missouri
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St Louis, Missouri, Forenede Stater, 63136
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Montana
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Billings, Montana, Forenede Stater, 59101
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New York
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Nyack, New York, Forenede Stater, 10960
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Texas
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Dallas, Texas, Forenede Stater, 75204
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Avignon, Frankrig, 84082
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Bordeaux, Frankrig, 33076
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Bordeaux, Frankrig, 33075
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Chambray-lès-tours, Frankrig, 37044
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Limoges, Frankrig, 87042
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Nimes, Frankrig, 30029
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Pessac, Frankrig, 33604
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Rouen, Frankrig, 76031
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Heraklion, Grækenland, 71110
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Thessaloniki, Grækenland, 56439
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Beer Sheva, Israel, 8410101
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Jerusalem, Israel, 91031
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Kfar Saba, Israel, 44281
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Petach Tikva, Israel, 49100
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Ramat-gan, Israel, 52621
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Rehovot, Israel, 76100
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Tel Aviv, Israel, 6423906
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Bergamo, Italien, 24128
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Cattolica, Italien, 47841
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Rimini, Italien, 47900
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Udine, Italien, 33100
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Buchun, Korea, Republikken, 420-021
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Seoul, Korea, Republikken, 138-736
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Seoul, Korea, Republikken, 110-744
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Seoul, Korea, Republikken, 120-752
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Seoul, Korea, Republikken, 133-792
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Seoul, Korea, Republikken, 137-040
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Split, Kroatien, 21000
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Zagreb, Kroatien, 10000
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Bialystok, Polen, 15-073
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Krakow, Polen, 31-501
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Warszawa, Polen, 02-781
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Warszawa, Polen, 04-394
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San Juan, Puerto Rico, 00921-3201
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Belgrade, Serbien, 11000
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Bratislava, Slovakiet, 831 01
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Ljubljana, Slovenien, 1000
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Barcelona, Spanien, 08907
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Leganes, Spanien, 28911
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Madrid, Spanien, 28041
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Madrid, Spanien, 28035
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Palma de Mallorca, Spanien, 07014
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Cape Town, Sydafrika, 7500
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Durban, Sydafrika, 4001
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Pietermaritzburg, Sydafrika, 3201
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Port Elizabeth, Sydafrika, 6001
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Pretoria, Sydafrika, 0001
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Kueishan, Taiwan
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Tainan, Taiwan, 704
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Taipei, Taiwan, 104
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Tübingen, Tyskland, 72076
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- adult patients >=18 years of age;
- metastatic colorectal cancer;
- >=1 target lesion;
- failed first-line chemotherapy with 5-fluorouracil and irinotecan.
Exclusion Criteria:
- previous treatment with oxaliplatin;
- progressive or recurrent disease during or within 6 months of completion of first-line chemotherapy;
- >=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic disease.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: XELOX
Participants received XELOX (oxaliplatin and capecitabine).
Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine.
Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
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1000mg/m2 po bud på dag 1-15 i hver 3 ugers cyklus
As prescribed, in 3 week cycles
As prescribed, in 2 week cycles
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Aktiv komparator: FOLFOX-4
Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination).
Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours.
On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours.
It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
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As prescribed, in 3 week cycles
As prescribed, in 2 week cycles
As prescribed, in 2 week cycles
As prescribed, in 2 week cycles
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Progression Free Survival
Tidsramme: Up to 3 years
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Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause.
It was based on tumor assessments made according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0, wherein progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions (TLs), taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-target lesions.
Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed.
Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization
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Up to 3 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Progression Free Survival Based on Independent Review Committee Assessment
Tidsramme: Up to 3 years
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Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause.
It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs.
Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed.
Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization.
This PFS evaluation was based on Independent Review Committee Assessment.
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Up to 3 years
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Progression Free Survival Based on Treatment Analysis- Intent To Treat Population
Tidsramme: Up to 3 years
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Progression free survival (PFS) is defined as the time from date of randomization to day of documented disease progression or death from any cause.
It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs.
Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed.
Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization.
PFS was analyzed using an on-treatment approach included only disease progression and death that occurred no later than 28 days after the last confirmed intake of study medication in the primary study treatment phase.
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Up to 3 years
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Progression Free Survival Based on Treatment Analysis- Per Population
Tidsramme: Up to 3 years
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Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause.
It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs.
Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed.
Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization
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Up to 3 years
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Best Overall Response, Investigators' Assessments
Tidsramme: Up to 3 years
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Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include complete response (CR), partial response (PR), or stable disease (SD).
CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level.
PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD.
SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started.
It was dependent on achievement of measurement and confirmation criteria.
BOR .i.e.
CR or PR was confirmed by repeat assessments performed within 4 weeks.
For SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks.
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Up to 3 years
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Best Overall Response, Independent Review Committee Assessment
Tidsramme: Up to 3 years
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Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include CR, PR, or SD.
CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level.
PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD.
SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started.
It was dependent on achievement of measurement and confirmation criteria.
BOR .i.e.
CR or PR was confirmed by repeat assessments performed within 4 weeks, for SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks.
This PFS evaluation was based on Independent Review Committee Assessment.
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Up to 3 years
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Overall Survival
Tidsramme: Up to 3 years
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Overall survival was measured as the time from the date of randomization to the date of death.
Participant who were not reported to have died at the time of the analysis were censored using the date they were last known to be alive.
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Up to 3 years
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Time To Response
Tidsramme: Up to 3 years
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Time to response (TOR) (best response of CR or PR) was measured as the time from randomization to the first date on which the measurement criteria for CR or PR (whichever status was recorded first) were met.
CR for TLs was defined as disappearance of all TLs and for non-TLs as disappearance of all non-TLs and normalization of tumor marker level.
PR was defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD.
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Up to 3 years
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Duration Of Response
Tidsramme: Up to 3 years
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Duration of response (DOR) is defined as the time when CR or PR was first met up to first date that PD or death is documented.
CR is defined as disappearance of all TLs and non TLs, PR is defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD.
PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions for the TLs or the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs.
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Up to 3 years
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Time To Treatment Failure
Tidsramme: Up to 3 years
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Time to treatment failure was defined as the time from the date of randomization to the first occurrence of adverse event (AE), insufficient therapeutic response, death, failure to return, or refusing treatment/being uncooperative/withdrawing consent.
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Up to 3 years
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Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment
Tidsramme: Up to 3 years
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Laboratory abnormalities were defined as those values that were outside the Roche defined reference range and showed a clinically relevant change from baseline.
All laboratory parameters were categorized according to the National Cancer Center Common Toxicity Criteria (NCI-CTCAE) grading system.
Incidence of Grade 1 to 4 laboratory abnormalities are presented in the table below.
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Up to 3 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2003
Primær færdiggørelse (Faktiske)
1. august 2006
Studieafslutning (Faktiske)
1. august 2006
Datoer for studieregistrering
Først indsendt
15. september 2003
Først indsendt, der opfyldte QC-kriterier
17. september 2003
Først opslået (Skøn)
18. september 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. marts 2016
Sidst verificeret
1. marts 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kolorektale neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Beskyttelsesagenter
- Mikronæringsstoffer
- Vitaminer
- Modgift
- Vitamin B kompleks
- Capecitabin
- Oxaliplatin
- Leucovorin
Andre undersøgelses-id-numre
- NO16967
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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